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BerGenBio

Earnings Release May 23, 2017

3555_rns_2017-05-23_2e8d528c-d129-4608-8a1b-a5ffdeedf603.html

Earnings Release

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BerGenBio ASA: Results for the First Quarter 2017

BerGenBio ASA: Results for the First Quarter 2017

Bergen, Norway, 23 May 2017 - BerGenBio ASA, a clinical-stage biopharmaceutical

company developing novel, selective Axl kinase inhibitors for multiple cancer

indications, announces its results for the first quarter 2017. A presentation of

the results by the company's senior management team will take place today at

10:00a.m. CET in Oslo - details below.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"During Q1 2017, BerGenBio has established a strong foundation from which to

advance our development strategy for BGB324, a first-in-class, selective, oral

Axl inhibitor, which has already delivered compelling clinical data in difficult

-to-treat cancer patients. BerGenBio's leadership in Axl inhibition ideally

positions the company to address a major opportunity by developing new medicines

to treat aggressive haematological and solid cancers, that evade the immune

system, acquire resistance to cancer drugs and metastasise. The funds from our

recent IPO will enable the company to complete our ongoing Phase II trials with

BGB324 as a single agent and in combination with chemo- and immunotherapies"

Operational Highlights

Phase II clinical development program opened and enrolling

· Lung cancer study in combination with erlotinib opened in first and second

line setting.

· Lung cancer study in combination with docetaxel opened & dosed first

patients

· Melanoma study in combination with targeted & I-O therapies opened and dosed

first patients

Collaborative agreement with Merck & Co (MSD)

· Phase II combination trials (2) with MSD's immune checkpoint inhibitor

KEYTRUDA® (pembrolizumab) in patients with advanced lung cancer and triple

negative breast cancer

Board of Directors strengthened with appointment of Stein H. Annexstad as

Chairman

Registered wholly owned subsidiary BerGenBio Limited, to facilitate UK

organization

IPO launched and preparations made to list on Oslo Stock Exchange

Grant from the Research Council

· BerGenBio awarded a NOK 15.7 million grant from the Research Council of

Norway under the program for user-managed innovation arena (BIA)

Post-period events

IPO achieved, raising NOK 400 million from new and existing investors to fund

further clinical development of BGB324 and pipeline programs

· BerGenBio shares began trading on OSE on 7 April 2017 under the ticker

BGBIO.

Presentations (2) at the American Association for Cancer Research (AACR) Annual

Meeting 2017:

· Presentation of a Phase II randomized clinical study with BGB324 in melanoma

· Preclinical data of BGB324 in models of lung and breast cancer confirmed Axl

to be a key factor in tumor resistance to cancer immune checkpoint inhibitors

(CPIs) and a valid drug target. Data also showed that BGB324 treatment led to

activation of the anti-tumor immune response.

Financial Summary

(NOK million) Q1 2017 Q1 2016 FY 2016

Operating revenues - - -

Operating expenses 65.8 20.7 131.6

Operating profit (loss) (65.8) (20.7) (131.6)

Profit (loss) after tax (65.1) (20.3) (129.8)

Basic and diluted earnings (loss) per share (NOK) (1.93) (75.21) (419.7)

Cash position end of period 95.4 163.2 161.8

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place at 10:00 am

CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Tjuvholmen

The presentation will webcast live and the link will be available at

www.bergenbio.com in the section Investors/Reports and presentations/Webcasts. A

recording will be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com

in the section: Investors/Reports and presentations from 7:00 am CET the same

day.

-Ends-

About BerGenBio ASA

BerGenBio (Bergen, Norway) is a clinical-stage biopharmaceutical company focused

on developing a pipeline of first-in-class AXL kinase inhibitors to treat

multiple cancer indications. The Company is a world leader in understanding the

central role of AXL kinase in promoting cancer spread, immune evasion and drug

resistance in multiple aggressive haematological and solid cancers.

BGB324, is a selective, potent and orally available small molecule AXL inhibitor

in Phase II clinical development in four major cancer indications. It is the

only selective oral AXL inhibitor in clinical development. BGB324 is being

developed by BerGenBio as a single agent therapy in acute myeloid leukaemia

(AML)/myeloid dysplastic syndrome (MDS) and in combination with TARCEVA®

(erlotinib) in advanced non-small-cell lung cancer (NSCLC); and in combination

with KEYTRUDA® (pembrolizumab) in advanced NSCLC and triple negative breast

cancer (TNBC) in collaboration with MSD.

The Company is also developing a diversified pre-clinical pipeline of selective

AXL inhibitors including BGB149, anti-AXL monoclonal antibody.

For further information, please visit: www.bergenbio.com

Contacts

Richard Godfrey

CEO, BerGenBio ASA

[email protected]

+47 917 86 304

David Dible, Mark Swallow, Marine Perrier

Citigate Dewe Rogerson

[email protected]

+44 207 638 9571

Forward looking statements

This announcement may contain forward-looking statements, which as such are not

historical facts, but are based upon various assumptions, many of which are

based, in turn, upon further assumptions. These assumptions are inherently

subject to significant known and unknown risks, uncertainties and other

important factors. Such risks, uncertainties, contingencies and other important

factors could cause actual events to differ materially from the expectations

expressed or implied in this announcement by such forward-looking statements

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.

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